FDA Takes Action on Opioids Labeling — It’s about education

Searcy Denney Scarola Barnhart & Shipley

Searcy Denney Scarola Barnhart & Shipley

Opioid Education

The U.S. Food and Drug Administration (FDA) crept cautiously closer to curbing the opioid crisis by approving sweeping changes as to how the prescription drugs are labeled.

Going forward, such medications must have a boxed warning that includes the Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS), an initiative aimed at teaching patients and providers about the dangers of using the addictive substances.

“The strategy will encourage providers to participate in an educational program to ensure they are safely administering opioids to patients for acute pain management, as well as counseling patients on safely taking, storing, and disposing of the medication,” states an article on ConsumerSafety.org titled “FDA Approves New Labeling on Opioid Drugs.” “It will also encourage patients and caregivers to read medication guides when they are provided by pharmacists.”

The REMS, which since 2012 has applied to extended-release / long-acting opioids, now applies to immediate-release opioids such as codeine, fentanyl, morphine and oxycodone – among others – that rank as top killers because of overdoses. In 2017, the latest year for which statistics are available, opioids were linked to 72,000-plus deaths.

“The update comes as a necessary defense against the opioid epidemic, as a 30% increase in opioid overdoses was reported in the United States from July 2016 to September 2017,” according to the ConsumerSafety.org article. “Although effective at treating both acute and chronic pain, it is no secret that opioids come with serious, and sometimes fatal, side effects that may outweigh the benefit for some users. Along with physical effects like nausea and vomiting, individuals may also experience mood swings, depression, panic attacks, and potentially more severe withdrawal symptoms and lasting health problems.”

The REMS initiative merely encourages providers to complete a training program on opioids that drug companies must make available. But an FDA news release says mandatory training might be added to the new labeling protocol in the future.

“There is no mandatory federal requirement that prescribers or other health care providers take the training provided through the REMS and completion of the training is not a precondition to prescribing opioid analgesics to patients,” says the news release, titled “FDA takes important steps to encourage appropriate and rational prescribing of opioids through final approval of new safety measures governing the use of immediate-release opioid analgesic medications.” “However, the FDA’s Opioid Policy Steering Committee continues to consider whether there are circumstances when the FDA should require some form of mandatory education for health care providers and how the agency would pursue such a goal.”

Besides encouraging providers to complete a training program on opioids, the boxed warning encourages them to “counsel patients and / or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal,” as well as “emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist.”

“As part of the U.S. Department of Health and Human Services’ Five-Point Strategy to Combat the Opioid Crisis, the FDA remains committed to addressing the national crisis of opioid addiction on all fronts, with a significant focus on decreasing unnecessary and / or inappropriate exposure to opioids and preventing new addiction; supporting the treatment of those with opioid use disorder; fostering the development of novel pain treatment therapies and opioids more resistant to abuse and misuse; and taking action against those who contribute to the illegal importation and sale of opioid products,” the news release says. “The FDA will also continue to evaluate how drugs currently on the market are used, in both medical and illicit settings, and take regulatory action where needed.”

Opioids more often than not serve as a gateway drug to heroin, the illicit street substance that also is categorized as an opioid, although it is illegal. The National Institute on Drug Abuse (NIDA), part of the U.S. Department of Health & Human Services’ National Institutes of Health, reports that 75 percent of heroin users said they took prescription opioids.

“In addition to efforts to prevent initiation of abuse of prescription opioids and use of heroin, there is a significant need to identify and treat people who have already developed an addiction to these substances,” according to a page on NIDA’s Web site. “The prescription drug monitoring programs are one means by which states are identifying individuals who are doctor shopping. In addition, there are ongoing efforts to encourage health care practitioners to screen patients for potential drug abuse problems. However, identification is only the first step; it is critical to provide evidence-based treatments for these individuals.”

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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